Effect of postoperative synbiotics on bacterial infections after liver transplantation: A randomized double-blind...

Previous trials have reported significant reductions in posttransplant bacterial infections with pre-, peri-, or postoperative treatment with probiotics, with or without additional prebiotics. However, uncertainty remains regarding the veracity of these results, and we are not aware of the adoption of such treatment by transplant centers. We sought to confirm the efficacy of postoperative synbiotic treatment in reducing posttransplant infections in a randomized, double-blind, placebo-controlled trial. Eighty-two patients wait-listed for liver transplantation were randomized to receive a daily dose of either a synbiotic (400 billion lactic acid bacteria plus 4 bioactive fibers) or a placebo (nonfermentable fiber) administered as soon as possible after surgery and continued for 14 days. Infectious complications (primary outcome), antibiotic use, and adverse events were recorded during the first 30 postoperative days. Patients were followed up for 90 days for rejection and survival. The primary analysis was by intention-to-treat. In addition, a per-protocol analysis was carried out, excluding patients who failed to reach 80% of the prescribed dose of synbiotics or placebo. One patient withdrew consent after randomization, and the remaining 81 patients (39 synbiotic and 42 placebo) constituted the intention-to-treat population. Bacterial infectious complications occurred in 15 (38.5%) synbiotic and 14 (33.3%) placebo patients (adjusted p =0.68). There was 1 death in the synbiotic group and 2 deaths in the placebo group. Rejection occurred in 12 (30.8%) synbiotic and 17 (40.5%) placebo patients ( p =0.49). The median (range) postoperative hospital stay was 9 (4-33) days for synbiotic and 9 (6-125) days for placebo patients ( p =0.90). Per-protocol analyses did not markedly change these results. In conclusion, postoperative synbiotic supplementation did not provide significant clinical outcome benefits in patients undergoing liver transplantation.